In working with medical device and biopharma companies, I have gathered common mistakes about CAPA reporting:
- not identifying other systemic issues
- not documenting what was identified as not a contributor after testing each probable contributing causes
- not identifying effectiveness checks
- not monitoring (may use spreadsheet to document meeting minutes,updates ,records,files)
- not all audit results that needs improvements needs to have a CAPA
- not looking at trends from archive data for measurements,KPIs,test results,other quality data
- not segragating and isolating defectives
- no training for those who writes CAPA reports
- no open communication to all parties and outside customers involved in the process
- inadequate plan or forms, to document trace to complaints and other sources of deviations/variations/customer dissatisfaction
See Archiving SPC-related Data using Infinity QS Database Manager
[…] Common mistakes about CAPA, corrective and preventive actions. […]
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